Robinson Bradshaw

Topic: Navigenics

As deCODE Departs, 23andMe Reloads

A day after Amgen purchased deCODE Genetics for a whopping $415M, in part for access to its unique data (as described in yesterday’s post), 23andMe announced today it had raised $50M in new financing as part of a concerted effort to grow its genetic database to one million customers. Both events underscore the increasing importance of data […]

Implications of Amgen/deCODE Deal for Genetic Testing Consumers

The big biotech news of the day is the $415 million sale of deCODE Genetics to Amgen. Coverage of the deal is everywhere, including a typically excellent overview from Matthew Herper of Forbes. We’ve written extensively about deCODE here at the Genomics Law Report over the years, including the company’s well-publicized bankruptcy and privatization two years ago. […]

DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing

This morning, Gene By Gene, Ltd. – better known as the parent company of the popular genetic genealogy provider Family Tree DNA – formally announced a corporate reorganization that includes the debut of a new division, DNA DTC. (Apparently the news was also announced earlier this month at the Family Tree DNA Conference, although the company […]

Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions

Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”. 23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical […]

Update: FDA Taking Another (Public) Look at DTC Genetic Tests

Direct-to-consumer (DTC) genetic tests are back on the FDA’s public radar screen. A month from today, the agency’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet to “discuss and make recommendations on scientific issues concerning [DTC] genetic tests that make medical claims.” Here is the Federal Register notice (pdf). The […]

2011 Personal Genomics Preview: It’s Déjà Vu…

Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked: 1. Will the $1,000 genome live up to the hype? 2. Will personal genomics stay DTC? 3. How will the ongoing gene patent debate affect the progress of personalized medicine? 4. […]

The Past, Present and Future of DTC Genetic Testing Regulation

[Editor’s Note: Newsweek science editor Mary Carmichael has a DNA Dilemma. As Carmichael debates whether to take a direct-to-consumer (DTC) genetic test, she is soliciting feedback from the DTC community, from the public and from other commentators, including myself. At the end of the week, she will make her decision. On Tuesday, Carmichael and five […]

“From Gulf Oil to Snake Oil”: Congress Takes Aim at DTC Genetic Testing

It has been a busy week in Washington for direct-to-consumer (DTC) genetic testing companies. Following public FDA meetings and a new round of FDA device notification letters earlier in the week, representatives from three major DTC genetic testing companies (23andMe, Navigenics and Pathway Genomics) were hauled in front of Congress today to defend their companies, their […]

While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers

Earlier this week the FDA held a widely publicized two-day public meeting to discuss its planned regulation of laboratory developed tests (LDTs) (for more see: Day One Recap and Day Two Recap). Other than Monday morning, when the FDA presented background information on LDTs and some of the considerations that have pushed the Agency to […]

The Conversation Continues: Recap from Day Two of FDA’s Regulatory Meeting

The second and final day of the FDA’s “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs) brought forth many of the same comments and themes as the first. The primary difference was that, whereas the first day began with some comments from the Agency that provided a few hints about what the FDA has […]